Combination of gemcitabine, nab-paclitaxel, and S-1(GAS) as the first-line treatment for patients with locally advanced or advanced pancreatic ductal adenocarcinoma: study protocol for an open-label, single-arm phase I study.

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  • Author(s): Chang C;Chang C; Li X; Li X; Cao D; Cao D
  • Source:
    BMC cancer [BMC Cancer] 2021 May 13; Vol. 21 (1), pp. 545. Date of Electronic Publication: 2021 May 13.
  • Publication Type:
    Clinical Trial Protocol; Journal Article
  • Language:
    English
  • Additional Information
    • Source:
      Publisher: BioMed Central Country of Publication: England NLM ID: 100967800 Publication Model: Electronic Cited Medium: Internet ISSN: 1471-2407 (Electronic) Linking ISSN: 14712407 NLM ISO Abbreviation: BMC Cancer Subsets: MEDLINE
    • Publication Information:
      Original Publication: London : BioMed Central, [2001-
    • Subject Terms:
      Albumins*/administration & dosage ; Albumins*/adverse effects ; Antineoplastic Combined Chemotherapy Protocols*/therapeutic use ; Carcinoma, Pancreatic Ductal*/drug therapy ; Carcinoma, Pancreatic Ductal*/mortality ; Deoxycytidine*/administration & dosage ; Deoxycytidine*/adverse effects ; Deoxycytidine*/analogs & derivatives ; Oxonic Acid*/administration & dosage ; Oxonic Acid*/adverse effects ; Paclitaxel*/administration & dosage ; Paclitaxel*/adverse effects ; Pancreatic Neoplasms*/drug therapy ; Pancreatic Neoplasms*/mortality ; Tegafur*/administration & dosage ; Tegafur*/adverse effects; Adolescent ; Adult ; Aged ; Female ; Humans ; Male ; Middle Aged ; Young Adult ; Drug Combinations ; Gemcitabine ; Clinical Trials, Phase I as Topic
    • Abstract:
      Background: Pancreatic ductal adenocarcinoma (PDAC) is still a highly fatal malignancy among the most common cancers. More powerful treatments are expecting to bring hope for patients. Biweekly gemcitabine/nab-paclitaxel/S-1 (GAS) was proved safe and effective for patients with locally advanced pancreatic cancer in Japan. The objective of this study is to evaluate the feasibility and toxicity of GAS (repeated every 3 weeks) in the treatment of locally advanced or advanced pancreatic cancer and determine the recommended dose of S-1 in this combination.
      Methods: This is an open-label, single-arm, and single-center phase I trial. Patients who have been diagnosed with locally advanced or advanced PDAC pathologically without previous systemic treatments will be enrolled and be treated with GAS chemotherapy every 3 weeks (nab-paclitaxel 125 mg/m 2 , ivgtt, day1, 8; gemcitabine 1000 mg/m 2 , day1, 8; different doses of S-1 within a dose escalation scheme) until the presence of disease progression (PD), intolerable adverse events (AEs), or requirement of patients and researchers. The primary endpoints are maximum tolerated dose (MTD) and dose-limiting toxicity (DLT). The secondary endpoints include safety, objective response rate (ORR), progression-free survival (PFS) and overall survival (OS).
      Discussion: This trial will adjust the administration of GAS to make it more effective for Chinese patients, while exploring the toxicity and feasibility of this adjustment.
      Trial Registration: ChiCTR, ( ChiCTR1900027833 ). Registered 30 November 2019.
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    • Grant Information:
      81773097 National Natural Science Foundation of China
    • Contributed Indexing:
      Keywords: Clinical protocol; Combination therapy; Gemcitabine; Nab-paclitaxel; Pancreatic ductal adenocarcinoma; S-1
    • Accession Number:
      0 (130-nm albumin-bound paclitaxel)
      0 (Albumins)
      0W860991D6 (Deoxycytidine)
      0 (Drug Combinations)
      0 (Gemcitabine)
      5VT6420TIG (Oxonic Acid)
      P88XT4IS4D (Paclitaxel)
      150863-82-4 (S 1 (combination))
      1548R74NSZ (Tegafur)
    • Publication Date:
      Date Created: 20210514 Date Completed: 20211018 Latest Revision: 20240327
    • Publication Date:
      20240327
    • Accession Number:
      PMC8117556
    • Accession Number:
      10.1186/s12885-021-08275-9
    • Accession Number:
      33985455